Spanish Validation of Tool Questionnaire to Assess Patients´Perception About Antipsychotic Treatment
TOOL
1 other identifier
observational
250
1 country
32
Brief Summary
Non-interventional, prospective study to validate Spanish version of TOOL questionnaire in patients with schizophrenia and bipolar disorder under antipsychotic treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2008
Shorter than P25 for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 5, 2008
CompletedFirst Posted
Study publicly available on registry
June 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedDecember 10, 2010
December 1, 2010
5 months
June 5, 2008
December 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
TOOL questionnaire
15 days
PANSS & Young Mania Scale
15 days
Secondary Outcomes (3)
Montgomery Asberg Depression Scale
15 days
Euroqol 5D & SF-36D
performed only at baseline visit
UKU modified scale
performed only at baseline visit
Eligibility Criteria
Patient aged 18-year old or older who has been diagnosed as schizophrenia or bipolar disorder
You may qualify if:
- Schizophrenia and bipolar disorder (DSM-IV criteria)
- Stabilized out-patients
- Treated with the same oral antipsychotic at least in the last month
You may not qualify if:
- Participation in another clinical trial within 6 months prior to enrolment into this study
- Administration of a depot antipsychotic medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (32)
Research Site
Vitoria-Gasteiz, Alava, Spain
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Palma, Balearic Islands, Spain
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Gavà, Barcelona, Spain
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Burgos, Burgos, Spain
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Puerto Real, Cadiz, Spain
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Santander, Cantabria, Spain
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Castellon, Castellon, Spain
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Ceuta, Ceuta, Spain
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A Coruña, Coruna, Spain
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Atarfe, Granada, Spain
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Granada, Granada, Spain
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Arrasate / Mondragón, Guipuzcoa, Spain
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Donostia / San Sebastian, Guipuzcoa, Spain
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Linares, Jaen, Spain
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León, Leon, Spain
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Alcobendas, Madrid, Spain
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Madrid, Madrid, Spain
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Parla, Madrid, Spain
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Estepona, Malaga, Spain
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Málaga, Malaga, Spain
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Murcia, Murcia, Spain
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Elizondo, Navarre, Spain
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Pamplona, Navarre, Spain
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Tudela, Navarre, Spain
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Pontevedra, Pontevedra, Spain
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Oviedo, Principality of Asturias, Spain
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Salamanca, Salamanca, Spain
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Tarragona, Tarragona, Spain
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Alzira, Valencia, Spain
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Sagunto, Valencia, Spain
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Galdako, Vizcaya, Spain
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Zamudio, Vizcaya, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Angel L Montejo
University of Salamanca
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 5, 2008
First Posted
June 6, 2008
Study Start
March 1, 2008
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
December 10, 2010
Record last verified: 2010-12